Trial · NCT00578786
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test | Baseline | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | Meters | MEAN |
| PRIMARY | Frequently Reported (15% or More Overall) Adverse Events by Severity | Baseline to Week 295 | Safety Analysis Set: Includes all participants who received at least 1 dose of AMB in one of the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Treatment group assignments for the safety analysis set were based upon the highest dose of AMB received at any time during the parent or extension studies. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test | Baseline to Week 24 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | Meters | MEAN |
| SECONDARY | Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test | Baseline to Week 48 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | Meters | MEAN |
| SECONDARY | Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test | Baseline to Year 2 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | Meters | MEAN |
| SECONDARY | Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test | Baseline to Year 3 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | Meters | MEAN |
| SECONDARY | Baseline Borg Dyspnea Index | Baseline | All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Year 1 in Borg Dyspnea Index | Baseline to Year 1 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Year 2 in Borg Dyspnea Index | Baseline to Year 2 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Year 3 in Borg Dyspnea Index | Baseline to Year 3 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. The LOCF method of imputation was used; only postbaseline observations were carried forward. | units on a scale | MEAN |
| SECONDARY | Baseline World Health Organization (WHO) Functional Class | Baseline | All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. | participants | NUMBER |
| SECONDARY | Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class | Baseline to Year 1 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values imputed using LOCF based on post-baseline observations. | participants | NUMBER |
| SECONDARY | Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class | Baseline to Year 2 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in extension study. Missing values were imputed using LOCF based on post-baseline observations. | participants | NUMBER |
| SECONDARY | Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class | Baseline to Year 3 | All assessments of efficacy were performed using the randomized analysis set; subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the extension study. Missing values were imputed using LOCF based on post-baseline observations. | participants | NUMBER |
| SECONDARY | Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group | Baseline | All participants were combined into one group for this analysis (all doses) and an observed-case approach was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group | Baseline to Week 12 | All participants were combined into one group for this analysis (all doses) and an observed-case approach was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group | Baseline to Week 24 | All participants were combined into one group for this analysis (all doses) and an observed-case approach was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group | Baseline to Week 36 | All participants were combined into one group for this analysis (all doses) and an observed-case approach was used. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With No Clinical Worsening of PAH | Baseline to Year 3 | All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. | percent probability (KM estimate) | NUMBER |
| SECONDARY | Percentage of Participants With Failure-Free Treatment Status | Baseline to Year 4 | All assessments of efficacy were performed using the randomized analysis set, such that subjects were allotted to an individual dose group based upon their randomized treatment assignment in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. | percent probability (KM estimate) | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00578786/outcomes